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Vitrolife Interim / Quarterly Report 2008

Apr 28, 2008

2989_10-q_2008-04-28_e4820a74-ee9c-4df0-812d-ebb509cf5f79.pdf

Interim / Quarterly Report

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Interim report January–March 2008 Strong sales and income growth

  • Sales increased by 19 percent to SEK 58.7 (49.2) million. Calculated in local sales currencies growth was 20 percent.
  • Gross income increased by 20 percent to SEK 40.5 (33.8) million, the gross margin was 69 percent (69).
  • Operating income increased by 33 percent and amounted to SEK 10.6 (8.0) million, which gives an operating margin of 18 (16) percent.
  • Operating income before research and development costs increased by 25 percent to SEK 18.3 (14.6) million. This corresponds to a margin of 31 (30) percent.
  • Consolidated net income was SEK 8.1 (11.0) million, which gives earnings per share of SEK 0.41 (0.55). However, last year's figure includes capitalization of the deferred tax asset in loss carry-forward for tax purposes to the tune of SEK 4.1 million. Adjusted for this item net income increased by 18 percent.

  • The cash flow from operating activities amounted to SEK 6.7 (5.0) million, an increase of 34 percent.

  • The equity/assets ratio amounted to 84 percent (82).
  • Acquisition of majority shareholding in Italian distributor.
  • Start of direct marketing of all fertility products in France announced.
  • Products for the cold storage of embryos approved in Canada and in Europe.
  • IVF products approved in Russia.

Sales and income MSEK 60

Vitrolife's net sales for the first quarter of 2008 amounted to SEK 58.7 (49.2) million, which corresponds to an increase of 19 percent compared to the previous year. Sales growth in local currencies was 20 percent. Translation of the American subsidiary's sales is affected negatively due to a weaker USD rate. However, this is counteracted to a certain extent by the fact that Vitrolife has a large proportion of its sales in Euro, which has developed positively. 20 40

Gross income was SEK 40.5 (33.8) million. The gross margin for the period was 69 (69) percent. The gross margin has, as was previously announced, been affected by the changeover in the production of fertility media from GIII to the new G5 Series™. The changeover means, amongst other things, double production and thereby higher costs. Company earnings have been affected by the double production during the last two quarters of 2007 and during the present quarter. The changeover process is now complete and will not affect the coming quarters. Operating income was SEK 10.6 (8.0) million, which corresponds to a margin of 18.0 percent (16.2). Selling expenses as a percentage of sales amounted to 24.5 percent (26.1), administrative expenses to 13.1 percent (14.3) and R&D costs to 13.1 percent (13.4). Depreciation and amortization of SEK 3.3 (3.2) million has been charged against the period. Rörelseresultat före FoU-kostnader Rörelseresultat före avskrivningar Resultat efter finansiella poster

As the company not only invests in the existing business operations but also in new technology, as for example a completely new transplantation method using STEEN Solution™, it is also relevant to assess operating profit before R&D costs. For the period operating profit before R&D costs amounted to SEK 18.3 (14.6) million, or 31.2 percent (29.6) of net sales. Fig 1. Net sales per geographic area (rolling 12 months) Fig 3. Income (rolling 12 months) Fig 2. Sales and income per quarter SEK millions

Net income amounted to SEK 8.1 (11.0) million. Net financial income amounted to SEK –1.3 (–1.0) million. Net financial income includes non-realized exchange rate fluctuations regarding internal receivables and liabilities of SEK –1.0 (0.2) million. The restatement of the Parent Company's loan and receivable regarding the American subsidiary Vitrolife, Inc. is booked directly against non-restricted equity. The restatement effect in the financial statements amounts to SEK –1.0 (0.2) million net. Minorities for the period amounted to SEK –0.2 (–) million and concern the minority interest in the Italian company A.T.S. Tax expenses for the period amounted to SEK –0.9 (tax revenue 4.0) million and these are current tax of SEK –0.2 (–) million, deferred tax on the Group's internal profits from inventories of SEK –0.7 (–0.1) million and capitalization of loss carry-forward of SEK– (4.1) million. At the end of 2007 Vitrolife had taxed loss carry-forward of SEK 163.7 (178.7) million. Of this amount, loss carry-forward for tax purposes for which deferred tax assets have not been recorded in the income statement and balance sheet amounted to approximately SEK 84.2 (157.7) million. Vitrolife annually updates its assessment of its future earning capacity and activates remaining losses to the extent necessary. These are offset against taxable earnings in the years to come.

Fertility products

  • Sales amounted to SEK 52.1 (44.3) million, an increase of 18 percent. Sales growth in local currencies was also 18 percent.
  • Acquisition of majority shareholding in Italian distributor.
  • Direct sales announced to be taken over from distributor in France.
  • Products for the cold storage of embryos approved in Canada and in Europe.
  • IVF products approved in Russia.

Sales in the Rest of the World region increased by 26 percent. The largest increase was seen in China and Japan.

Sales in the Europe/Middle East region increased by 22 percent during the period. UK and Belgium had the most positive development.

In January 2008 Vitrolife acquired 51 percent of the shares in A.T.S. Srl, the distributor of Vitrolife's products in Italy since 1999, for 448,000 Euro. The acquisition increases the opportunities for A.T.S. to be more aggressive and increase the market share in the Italian market. The seller of the shares was Paolo Trabucchi, one of the founders and previously the sole owner of A.T.S. Vitrolife has an option to acquire a further 9 percent of the shares within 6 months and subsequently a further 10 percent within 12 months, that is a total of 70 percent. Approximately 24,000 infertility treatments are performed in Italy per year and the number of fertility centers amounts to approximately 300. The potential market value for instruments and media amounts to SEK 40–50 million. The acquisition positively affects the consolidated sales figure for the first quarter of 2008 by SEK 2.4 million.

Furthermore, Vitrolife terminated the agreement for the distribution of media in France in January 2008, which will mean that from May 2008 both media and instruments will be marketed direct by Vitrolife in the French market. The two events in Italy and France are in line with Vitrolife's strategy to operate under its own management in key markets.

In the American region sales increased by 9 percent in local currency. The weakening of the USD meant that sales translated into SEK decreased by 2 percent compared with the previous year. Sales of fertility instruments were transferred from a distributor during the autumn of 2007, which has entailed training and a focus on these products.

In March Vitrolife obtained approval from Health Canada for two new products within the fertility area. The products, RapidVit™ Cleave and RapidWarm™ Cleave are used for so-called vitrification, rapid freezing and thawing of cleavage embryos (embryos day 2–3 after fertilization).

In April Vitrolife obtained approval in Europe (CE marking) for its new vitrification products. In addition to RapidVit™ Cleave and RapidWarm™ Cleave approval was also obtained for RapidVit™ Blast and RapidWarm™ Blast, for rapid freezing and thawing of blastocysts (embryos day 5–6 after fertilization). The latter two products obtained approval in Canada in December 2007.

Products for vitrification involve considerable technological progress and open up new opportunities within IVF treatment. Vitrification involves very rapid freezing, to prevent the formation of ice crystals that otherwise can cut the cells apart. In IVF fertilization more than 10 oocytes are often taken from the woman. A number of these are fertilized. The oocytes that are fertilized but not put back in the woman can then be kept in cold storage. It has been seen in the use of the vitrification method that survival increases considerably after cold storage compared with the method used previously. The chances thereby increase for the woman to become pregnant without her having to undergo new hormone treatment and the removal of more oocytes.

In April Vitrolife also obtained approval for its IVF nutrient solutions in Russia. The approval comprises 35 products. Russia is one of the markets that Vitrolife has decided to focus on. Penetration for IVF is relatively low today, but it is assessed that this market can grow faster than average during the coming years. 14,000 infertility treatments are today carried out each year and the number of fertility clinics amounts to approximately 50. The potential market value for nutrient solutions and instruments for IVF thereby amounts to approximately SEK 30 million today in Russia.

Transplantation products

  • Sales amounted to SEK 6.0 (4.8) million, an increase of 25 percent. Sales in local currencies increased by 31 percent.
  • Revenues from STEEN Solution™ have begun to come in, albeit to a limited extent.
  • Development of the documentation for STEEN Solution™ in the USA continuing according to plan.

Sales of transplantation products, primarily Perfadex® which has a market share of over 90 procent globally, increased by 31 percent in local currencies. The sales figure for the first quarter also now includes some sales of STEEN Solution™. When STEEN Solution™ becomes more clearly established in the clinics there will be additional good potential for further sales growth, above all in the important USA market. The timing of this depends amongst other things on sales approval. Activities to obtain sales approval, amongst other things in the USA, are proceeding according to plan and during the period Vitrolife has carried out training of clinics and demonstrations of the technology for target groups. Clinical studies are planned for STEEN Solution™ in North America, where there is great interest in this new technology, during quarters two to four of 2008.

The Stem Cell Cultivation product area is not reported separately as it is still at the research stage and sales are small. During the period they were SEK 0.6 (0.1) million. Research resources for the development of new products for stem cells have been increased since the summer of 2007 through the collaboration with Cellartis AB.

Investments and cash flow

Cash flow from operating activities amounted to SEK 6.7 (5.0) million for the period January–March 2008. The change in trade receivables, mainly accounts receivable, amounted to SEK –6.9 (–5.7) million. Investments in increased inventories amounted to SEK –1.1 (–2.3) million. The cash flow from investing activities was SEK –7.0 (–3.1) million. Gross investments in the Group's fixed assets amounted to SEK –1.4 (–1.9) million during the period and in intangible fixed assets to SEK –1.0 (–1.1) million. Intangible fixed assets for the period mainly consist of STEEN Solution™. The figures include the investment of SEK –4.6 (–) million in the subsidiary, after a deduction for acquired liquid funds. The investment involves the acquisition of 51 percent of the company's previous distributor in Italy, A.T.S. The cash flow from financing activities was SEK –1.1 (–1.1) million and it consists of the paying off of loans. In all, the cash flow for the period amounted to SEK –1.4 (0.8) million. The Group's liquid funds at March 31, 2008 amounted to SEK 16.8 (15.3) million. The equity/ assets ratio for the Group amounted to 84 (82) percent.

Parent Company

Business activities focus on company-wide management and the company has no employees. There were no revenues for the period (–). The costs that arise are mainly attributable to the Board and to the OMX Nordic Exchange and the listing of the company's shares. Income before tax amounted to SEK –1.6 (–0.1) million. Liquid funds amounted to SEK 0.7 (2.6) million. No investments were made during the period (–).

The Vitrolife share is listed on the OMX Nordic Exchange's Nordic Small Cap list under the symbol VITR. The closing price on March 31, 2008 was SEK 27.00 (35.40).

Organization and personnel

During the second half of 2007 an inventory of instrument products was built up, partly through temporarily employed personnel. This work is now complete and the number of positions, primarily temporary employees, therefore decreased during the first quarter. The sales organization has been strengthened during the period with product specialists, amongst other things for the French market.

During the first three months of 2008 the average number of employees was 135 (120), of whom 84 (77) were women and 51 (43) were men. 106 (94) people were employed in Sweden, 28 (26) in the USA and 1 (0) in Australia. The number of employees at the end of the period was 132 (124).

Information on transactions with related parties

No transactions that have substantially affected the company's financial position and results have been carried out with related parties during the period. For information on related parties, see the Annual Report for 2007, page 54.

Prospects for the whole year

During 2007 the largest product launch in five years was successfully carried out within the Fertility area. This meant a hectic period not only for the market organization but also for the whole product supply structure, with running-in periods and for a time double production runs. The launch meant both somewhat lower sales during the third and fourth quarters to existing customers during their testing phase and more expensive production costs. Sales growth during the first quarter of 2008 has been strong for the fertility products, plus 18 percent. The gross margin is at a good level, 69 percent, despite the fact that the margin includes certain lagging costs for the previous double production.

During the first part of 2008 Vitrolife has also continued to work in line with the strategy of strengthening R&D and the market organization. This is with a view to being able to successfully work up several key markets under company management with the aid of an increasingly strong product portfolio. Vitrolife is making greater and greater use of the potential market synergies that the strengthening of the product range with new products developed in-house and the acquisition of the instrument portfolio during 2006 create. 2008 began with Vitrolife acquiring direct marketing opportunities in the important markets of Italy and France, which means that large parts of Europe are now direct markets. The work on taking advantage of these opportunities is ongoing. The year will be characterized by a continued building up of the marketing resources, something which will favour the opportunities for continuing increased market shares within the Fertility area.

Within the Transplantation area the exciting development of STEEN Solution™ continues for the testing of organs outside the body. At present the focus is on the large North American market, where interest is very great and where the work on preparing the introduction of this new product is intensive. Amongst other things, clinical studies are planned for STEEN Solution™ during the coming quarters. The potential for significantly increased sales within the Transplantation area is very good looking a few years ahead. Vitrolife increased its research resources also within the stem-cell area during 2007 and strengthened the collaboration regarding the development of new media with Cellartis AB, a company strong in research within this area. Vitrolife anticipates that the stem-cell area can also come to be a commercially important part of the business as well a few years from now.

During the last quarter of 2008 the business in Sweden will move to new shared premises in Gothenburg. This is expected to simplify coordination above all within production, quality control and distribution, but also within product development.

Significant risks and uncertainty factors

During the period there have been no considerable changes in the Parent Company's and the Group's risks and uncertainty factors. For a review of risks and uncertainty factors, see the Annual Report for 2007, pages 34–35, 53 and 54.

Events after the end of the period

In April Vitrolife obtained European approval (CE marking) for its new vitrification products RapidVit™ Cleave, RapidWarm™ Cleave, RapidVit™ Blast and RapidWarm™ Blast. In addition, approval was obtained in Russia for a total of 35 of the company's nutrient solutions for IVF. For more information on these events, see above in the "Fertility products" section.

April 28, 2008 Kungsbacka, Sweden

Magnus Nilsson CEO

This is a translation of the Swedish version of the interim report. When in doubt, the Swedish wording prevails.

Consolidated income statements

January – March
SEK thousands 2008 2007 Whole year
2007
Net sales 58 670 49 210 188 939
Cost of goods sold –18 154 –15 453 –59 274
Gross income 40 516 33 757 129 665
Selling expenses –14 384 –12 822 –53 105
Administrative expenses –7 660 –7 060 –28 775
Research and development costs –7 702 –6 614 –26 889
Other operating revenues and expenses –181 706 138
Operating income 10 589 7 967 21 034
Financial income and expenses –1 343 –1 038 –2 628
Income after financial items 9 246 6 929 18 406
Minority interest –237
Taxes –916 4 040 17 651
Net income 8 093 10 969 36 057
Earnings per share, SEK 0.41 0.55 1.82
Earnings per share, SEK* 0.41 0.55 1.82
Average number of outstanding shares 19 800 157 19 790 157 19 790 990
Average number of outstanding shares* 19 864 027 19 790 157 19 865 309
Number of shares at closing day 19 800 157 19 790 157 19 800 157
Number of shares at closing day* 19 800 157 19 868 808 19 800 157

Depreciation and amortization has reduced income for the period by SEK 3 338 thousand (3 201).

* After dilution. Vitrolife has two outstanding share warrant programs, comprising 44 490 (1999) and 550 000 (2005) warrants. The net present values of the issue prices were higher than the share price at closing day in both programs. With regard to the average share price for the last 12 months, this was higher than the net strike price in the program from 1999, but lower than the net strike price with regard to the program from 2005.

Other key ratios
January – March
2008 2007 Whole year
2007
Gross margin, % 69.1 68.6 68.6
Operating margin, % 18.0 16.2 11.1
Operating margin before R&D costs, % 31.2 29.6 25.4
Net margin, % 13.8 22.3 19.1
Equity/assets ratio, % 83.7 81.5 84.6
Shareholders' equity per share, SEK 12.96 11.76 12.80
Shareholders' equity per share, SEK* 12.96 11.71 12.80
Return on equity, % 13.3 9.8 14.8
Return on capital employed, % 12.6 9.1 8.7

* After dilution, see above.

Consolidated income statements per quarter

SEK thousands Jan–Mar
2008
Oct–Dec
2007
Jul–Sep
2007
Apr–Jun
2007
Jan–Mar
2007
Oct–Dec
2006
Net sales 58 670 47 537 44 647 47 545 49 210 41 776
Cost of goods sold –18 154 –15 416 –14 144 –14 260 –15 453 –12 826
Gross income 40 516 32 121 30 503 33 285 33 757 28 950
Selling expenses –14 384 –13 807 –13 302 –13 175 –12 822 –12 747
Administrative expenses –7 660 –7 543 –6 612 –7 560 –7 060 –5 946
Research and development costs –7 702 –7 264 –6 437 –6 574 –6 614 –6 096
Other operating revenues and expenses –181 –349 –99 –121 706 –277
Operating income 10 589 3 158 4 053 5 855 7 967 3 884
Financial income and expenses –1 343 –155 –778 –655 –1 038 –1 817
Income after financial items 9 246 3 003 3 275 5 200 6 929 2 067
Minority interest –237
Taxes –916 4 861 4 427 4 322 4 040 73
Net income 8 093 7 864 7 702 9 522 10 969 2 140

Consolidated balance sheets

SEK thousands Mar 31, 2008 Mar 31, 2007 Dec 31, 2007
ASSETS
Goodwill 87 542 83 265 83 265
Other intangible fixed assets 23 255 24 945 24 030
Tangible fixed assets 72 137 82 612 76 639
Financial fixed assets 23 003 10 271 23 651
Inventories 42 685 30 781 42 562
Accounts receivable 30 854 30 971 26 378
Other current receivables 10 480 7 180 4 430
Liquid funds 16 802 15 336 18 505
Total assets 306 758 285 361 299 460
Share
holders
' equit
y and
liabilities
Shareholders' equity, attributable to the Parent Company's shareholders 256 654 232 641 253 384
Minority interest 412
Deferred tax liability 568 683 432
Long-term interest-bearing liabilities 12 631 20 157 14 304
Short-term interest-bearing liabilities 6 439 6 553 6 439
Accounts payable 10 963 10 989 9 505
Other short-term interest-free liabilities 19 091 14 338 15 396
Total shareholders' equity and liabilities 306 758 285 361 299 460
Pledged assets for own liabilities 30 000 30 000 30 000
Contingent liabilities None None None

Change in shareholders' equity

January – March Whole year
SEK thousands 2008 2007 2007
Amount at beginning of year 253 384 220 639 220 639
Translation difference –4 823 1 033 –3 621
New share issue 309
Net income for the period 8 093 10 969 36 057
Amount at end of period 256 654 232 641 253 384

Consolidated cash flow statements

January – March
SEK thousands 2008 2007 Whole year
2007
Income after financial items 9 246 6 930 18 406
Adjustment for items not affecting cash flow 4 180 2 945 13 668
Change in inventories –1 131 –2 323 –14 945
Change in trade receivables –6 852 –5 715 1 099
Change in trade payables 1 279 3 201 3 057
Cash flow from operating activities 6 722 5 038 21 285
Cash flow from investing activities –7 019 –3 061 –10 590
Cash flow from financing activities –1 145 –1 145 –6 528
Cash flow for the period –1 442 832 4 167
Liquid funds at beginning of year 18 505 14 470 14 470
Exchange rate difference in liquid funds –261 34 –132
Liquid funds at end of period 16 802 15 336 18 505

Income statements for the Parent Company

January – March Whole year
SEK thousands 2008 2007 2007
Administrative expenses –769 –261 –2 219
Research and development costs –4 –4 –17
Other operating revenues and expenses –4
Operating income –773 –265 –2 240
Financial income and expenses –815 140 –189
Income after financial items –1 588 –125 –2 429
Taxes 13 668
Net income –1 588 –125 11 239

Depreciation and amortization has reduced income for the period by SEK 18 thousand (18).

Balance sheets for the Parent Company

SEK thousands Mar 31, 2008 Mar 31, 2007 Dec 31, 2007
Assets
Patents 54 71 59
Tangible fixed assets 135 189 149
Participation in affiliated companies 322 806 317 986 317 986
Deferred tax assets 12 810 12 810
Receivables from affiliated companies 57 469 67 602 65 052
Other current receivables 909 113 502
Liquid funds 665 2 630 315
Total assets 394 848 388 591 396 873
Share
holders
' equit
y and
liabilities
Shareholders' equity 382 584 370 291 384 172
Long–term interest-bearing liabilities 4 081 11 027 5 609
Short-term interest-bearing liabilities 5 859 5 973 5 859
Accounts payable 1 233 217 189
Other short-term interest-free liabilities 1 091 1 083 1 044
Total shareholders' equity and liabilities 394 848 388 591 396 873
Pledged assets for own liabilities 3 100 3 100 3 100
Contingent liabilities 10 000 10 000 10 000

Note 1. Accounting principles

This interim report for the Group has been drawn up in accordance with the Annual Accounts Act and IAS 34, Interim Financial Reporting. Vitrolife reports in accordance with IAS 14, Segment Reporting, geographic areas as primary segment.

As from January 1, 2005, Vitrolife applies International Financial Reporting Standards (IFRS) in its consolidated accounts, in the form they have been adopted by the EU. As of January 1, 2005, the Parent Company applies RR 32, Accounting for Legal Entities. The main significance of RR 32 is that IFRS shall be applied, but with certain exceptions.

The accounting principles are unchanged compared with the last Annual Report and a description is to be found in the Annual Report for 2007.

Note 2. Financial data per geographic area, Group

January – March Whole year
SEK thousands 2008 2007 2007
Europe / Middle East
Net sales 38 839 31 597 113 359
Operating income 7 010 5 116 12 620
The Americas
Net sales 11 690 11 303 45 653
Operating income 2 110 1 830 5 082
Rest of world
Net sales 8 141 6 310 29 927
Operating income 1 469 1 022 3 332

Financial reports

Vitrolife's interim reports are published on the company's homepage, www. vitrolife.com, and are sent to the shareholders who have registered that they would like to have this information.

The interim report for the period January – June 2008 will be published on Tuesday July 15.

Queries should be addressed to:

Magnus Nilsson, CEO, phone +46 31 721 80 00 or +46 708 22 80 61. Anna Ahlberg, CFO, phone +46 31 721 80 13 or +46 708 22 80 13.

This report has not been the subject of review by the company's auditors.

The information in this report is such as that which Vitrolife is required to publish in accordance with the Securities Exchange and Clearing Operations Act.

www.vitrolife.com

Vitrolife AB (publ)

Faktorvägen 13 SE-434 37 Kungsbacka Sweden Corporate identity number 556354-3452. Tel +46 31 721 80 00 Fax +46 31 721 80 90 E-mail: [email protected]. Homepage: www.vitrolife.com

Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation. The Fertility product area works with nutrient solutions (media) and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to maintain tissue in optimal condition outside the body for the required time while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes. Vitrolife today has approximately 140 employees and the company's products are sold in more than 80 markets. The head office is in Kungsbacka, Sweden, and there are subsidiaries in Sweden, USA, Australia and Italy. The Vitrolife share is listed on the OMX Nordic Exchange Stockholm's Nordic Small Cap list.